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A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans with CKD

以患者为中心、基于系统的方法，改善 CKD 退伍军人的知情透析选择和结果

基本信息

批准号：
10607987
负责人：
Huanguang Jia
金额：
--
依托单位：
VETERANS HEALTH ADMINISTRATION
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-03-01 至 2025-09-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10607987
关键词：
18 year old Address Advocate Arkansas Awareness Blood Vessels Canada Caring Chronic Care Chronic Kidney Failure Clinical Clinical Services Consent Cost of Illness Data Decision Making Diagnosis Dialysis procedure Disease Disease Outcome Education Educational Models Effectiveness End stage renal failure Enrollment Europe European Fees Florida Glomerular Filtration Rate Goals Health Care Costs Health Promotion Health Services Health Services Accessibility Health system Healthcare Healthcare Systems Home Improve Access Inpatients Intervention Interview Kidney Kidney Diseases Knowledge Learning Logistic Regressions Managed Care Methods Modality Modeling Outcome Outpatients Outsourcing Patient Education Patient Outcomes Assessments Patient-Centered Care Patients Persons Pilot Projects Policy Maker Preparation Protocols documentation Random Allocation Regression Analysis Reporting Research Priority Risk Adjustment Services Societies Structure System Telemedicine Time Universities Veterans Visit care burden care costs cohort cost empowerment evidence base health related quality of life health service use improved meetings mortality patient oriented pilot test post intervention preference primary outcome programs prospective rural area satisfaction secondary outcome treatment as usual urban area

项目摘要

Background: CKD is the 4th most common diagnosis among Veterans. Each year 13,000 Veterans transition to ESRD. VHA supports over 52,000 ESRD Veterans on dialysis. The care of CKD costs VHA over $18 billion dollars annually. Transition care of these Veterans is uncoordinated and suboptimal as most receive their pre- ESRD care within VHA but over 90% are outsourced for their dialysis, on fee-basis. Thus, the majority of Veterans progressing to ESRD have limited awareness of CKD and its management options including the dialysis modalities. This leads to gross underuse (7%) of home dialysis (HoD). Professional renal societies and VHA national CKD program advocate informed dialysis choice, and greater use of HoD for all patients transitioning to ESRD. European and Canadian reports show that CPE empowers informed choice of dialysis, increases HoD use, and improves the quality of CKD care. However, availability of CPE within VHA is limited and HoD utilization is low. To address these issues, we have developed and pilot-tested a concise CPE model in two different universities and affiliated VA in Florida and Arkansas. Our preliminary findings show that CPE improves patient informed dialysis choice, and increases HoD selection to 74% and HoD use to 61%. In a separate pilot study, we found that tele-CPE is as efficacious as F2F-CPE. Objectives: The overall goal of this RCT is to investigate the impact of CPE on patient knowledge and confidence, HoD selection and use, and patient-reported, health services and clinical outcomes in a cohort of Veterans who were diagnosed with CKD and receive CKD treatment from the North Florida/South Georgia Veterans Health System (NF/SG VHS). The study aligns with HSR&D major research priorities including “patient-centered care, care management, and health promotion” and “health care systems change.” The 4 Specific Aims are: Aim 1: Compare the impact of CPE on Veterans’ knowledge of CKD, their confidence in dialysis decision making, and their selection of dialysis modality, between the CPE and usual care groups. Aim 2: Compare Veterans’ actual use of HoD (Primary Outcome) between the CPE and usual care groups. Aim 3: Examine Veterans’ perceived satisfaction with CPE, explore their preferences for F2F- or Tele-CPE, and investigate barriers and facilitators in the selection and use of their preferred dialysis modality. (Qualitative) Aim 4: Compare the following post-ESRD secondary outcomes between the CPE and usual care groups. Patient reported outcomes: 1) health-related quality of life and 2) satisfaction with dialysis; clinical outcomes: 3) time to ESRD, 4) estimated glomerular filtration rate at ESRD, 5) need for inpatient initiation of dialysis, and 6) vascular access status at ESRD; and health services utilization outcomes: 7) number of inpatient stays, and 8) number of outpatient visits, from enrollment to 90-day post ESRD period. Methods: In this mixed method RCT, we will enroll 800 Veterans with stage 4 or 5 CKD, ≥18 years of age, English speaking, and not yet on dialysis who receive CKD care from NF/SG VHS. In 1:1 ratio, all the consented Veterans will be randomly allocated into intervention (CPE) or control (enhanced usual care or EUC) group. For Aim 1, multiple regression analysis will be applied to model the risk-adjusted post-intervention CKD knowledge and confidence in Veteran dialysis decision making; For Aim 2, logistic regression will be used to compare the HoD selection and use between the CPE and EUC groups. Aim 3 will be a qualitative study using semi-structured interviews to obtain in-depth data on Veterans’ satisfaction with CPE, preference for CPE delivery, and barriers and facilitators to HoD selection and use as a dialysis. For Aim 4, multiple regression analysis will be applied to model the risk-adjusted effects of CPE, HoD, and the group-modality interaction on outcomes. Expected Results: We anticipate that CPE will enhance Veterans’ CKD knowledge and confidence for informed dialysis selection, and increase HoD use, leading to improved Veterans’ and health services outcomes. Next Step: If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.

背景：CKD是退伍军人中第四常见的诊断。每年有13，000名退伍军人到ESRD。VHA支持超过52，000名ESRD退伍军人进行透析。CKD的护理花费VHA超过180亿美元美元每年。这些退伍军人的过渡护理是不协调和次优的，因为大多数人接受他们的预- VHA内的ESRD护理，但超过90%的透析外包，收费。因此，大多数进展为ESRD的退伍军人对CKD及其管理方案的认识有限，包括透析方式。这导致家庭透析（HoD）使用严重不足（7%）。专业肾脏学会和 VHA国家CKD计划倡导知情的透析选择，并为所有患者更多地使用HoD 向ESRD过渡。欧洲和加拿大的报告显示，CPE使透析的知情选择，增加HoD的使用，并提高CKD护理的质量。但是，VHA内CPE的可用性有限 HoD利用率低。为了解决这些问题，我们已经开发并试点测试了一个简明的CPE模型在佛罗里达和阿肯色州的两所不同的大学和附属的弗吉尼亚州。我们的初步研究结果表明，CPE 改善患者知情的透析选择，并将HoD选择率提高到74%，HoD使用率提高到61%。中在单独的试点研究中，我们发现远程CPE与F2 F-CPE一样有效。目标：总体目标 RCT旨在研究CPE对患者知识和信心、HoD选择和使用以及诊断为CKD的退伍军人队列中的患者报告、卫生服务和临床结局并接受北佛罗里达/南格鲁吉亚退伍军人健康系统（NF/SG VHS）的CKD治疗。的这项研究与HSR&D的主要研究重点一致，包括“以病人为中心的护理，护理管理，健康促进”和“卫生保健系统的变化”。4个具体目标是：目标1：比较 CPE关于退伍军人对CKD的了解、他们对透析决策的信心以及他们对 CPE和常规护理组之间的透析方式。目标2：比较退伍军人实际使用HoD的情况（主要结果）之间的CPE和普通护理组。目标3：检查退伍军人的感知满意度了解他们对F2 F或Tele-CPE的偏好，并调查选择和使用首选的透析方式。（定性）目标4：比较以下ESRD后 CPE和常规护理组之间的次要结局。患者报告结局：1）健康相关生活质量和2）对透析的满意度;临床结局：3）至ESRD的时间，4）估计肾小球 ESRD时的滤过率，5）需要住院患者开始透析，以及6）ESRD时的血管通路状态;以及卫生服务利用结果：7）住院次数，8）门诊次数，从入组至ESRD后90天。方法：在这项混合方法RCT中，我们将招募800名退伍军人， CKD 4或5期，年龄≥18岁，会说英语，尚未接受透析治疗， NF/SG VHS。按照1：1的比例，所有同意的退伍军人将被随机分配到干预（CPE）或对照组（增强常规护理或EUC）。对于目标1，将对模型应用多元回归分析风险调整后的干预后CKD知识和对退伍军人透析决策的信心; 目的2，逻辑回归将用于比较CPE和EUC之间的HoD选择和使用组目标3将是一个定性研究，使用半结构化访谈，以获得深入的数据，退伍军人的对CPE的满意度，对CPE交付的偏好，以及HoD选择和使用的障碍和促进因素透析对于目标4，将应用多元回归分析对CPE、HoD、以及组-模态交互作用对结果的影响。预期成果：我们预计持续专业教育将提高退伍军人的CKD知识和对知情透析选择的信心，并增加HoD的使用，导致改善退伍军人和卫生服务成果。下一步：如果成功，这项研究可能会提供一个准备好，推出战略，以满足退伍军人的CKD护理需求，并降低VHA医疗保健成本。